Order in Council

Note

Changes authorised by subpart 2 of Part 2 of the Legislation Act 2012 have been made in this official reprint.

Note 4 at the end of this reprint provides a list of the amendments incorporated.

These regulations are administered by the Ministry for Primary Industries.

Pursuant to section 75 of the Agricultural Compounds and Veterinary Medicines Act 1997, His Excellency the Governor-General, acting on the advice and with the consent of the Executive Council and on the recommendation of the Minister for Food Safety made in accordance with section 78 of that Act, makes the following regulations.

2 Commencement

3 Interpretation

active ingredient means a chemical or biological component in a formulated product that is principally responsible for the effect being claimed and is distinct from other components of the formulated product such as adjuvants or additives

agricultural chemical means an agricultural compound other than one used or intended to be used in the direct management of animals; and does not include a vertebrate toxic agent

animal material means a live or dead animal, or any tissue or other natural material taken from a live or dead animal

compounded veterinary preparation means a preparation of 1 or more ingredients prepared by a veterinarian, or by a person who is not a veterinarian under contract to and under the instructions of the veterinarian, for use on animals as a veterinary medicine

compounding veterinarian means a veterinarian who prepares a compounded veterinary preparation or under whose instructions a compounded veterinary preparation is prepared

exempt compound product means a product that is an exempt agricultural compound specified in column 1 of Schedule 2 and that is intended for sale as a specific proprietary product

feed means edible material that—

(a)

provides nourishment in the form of energy and for building tissues; and

(b)

contributes to the normal physiological function and metabolic homeostasis of an animal

feed additive means a non-nutrient substance added to the feed of animals to improve the preservation, digestion, colour, palatability, texture, or nutritive value of the feed

fertiliser—

(a)

means a substance or biological compound or mix of substances or biological compounds that is described as, or held out to be suitable for, sustaining or increasing the growth, productivity, or quality of plants or, indirectly, animals through the application to plants or soil of—

(i)

nitrogen, phosphorus, potassium, sulphur, magnesium, calcium, chlorine, and sodium as major nutrients; or

(ii)

(iii)

(b)

includes non-nutrient attributes of the materials used in fertiliser; but

(c)

does not include substances that are plant growth regulators that modify the physiological functions of plants

fertiliser additive—

(a)

means a non-nutrient substance added to a fertiliser, or applied by itself to land or plants, that—

(i)

improves the supply and uptake of nutrients; or

(ii)

increases biological activity; or

(iii)

modifies the physical characteristics of a fertiliser to make it more fit for its purpose; but

(b)

does not include substances that are plant growth regulators that modify the physiological functions of plants

food crops means plants used as food or for food production for humans

intra-ruminal device means a device designed to be administered orally to a ruminant animal to provide prolonged and sustained release of nutrients or therapeutic or pharmacological substances or preparations

non-medicated, in relation to a product, means a product that does not contain any pharmacological or therapeutic substances

nutrient means a nourishing substance given orally, including, but not limited to,—

(a)

a constituent substance of feed that is necessary for, or contributes to, the natural and normal physiological function and metabolic homeostasis of an animal; and

(b)

nutritional benefit means a contribution to the normal physiological function and metabolic homeostasis of an animal achieved by the oral provision of nutrients

nutritional preparation means a compounded mix of nutrients or nutrients and feed additives

oral gastrointestinal-acting microflora-enhancing compound means a substance ingested by an animal, or a preparation intended for oral administration to an animal, solely to modify the conditions of the animal’s gastrointestinal tract to maintain or produce a normal or favourable microflora population

pharmacological substance means a substance that modifies a physiological function of an animal

plant material means any live or dead plant, or any tissue or other natural material taken from a live or dead plant

therapeutic substance—

(a)

means a substance designed to prevent, treat, or cure a disease or abnormal physiological condition; but

(b)

does not include a substance designed to prevent or treat subnormal levels of nutrients

topical, in relation to a substance or preparation, means the substance or preparation is applied only to the surface of the body, which—

(a)

includes the skin, hoof, nail, or hair; but

(b)

does not include the eye or the ear canal.

Prohibited agricultural compounds

4 Prohibition on use of certain agricultural compounds

(1)

The substances described in Schedule 1 are prohibited from use as agricultural compounds or as ingredients in agricultural compounds.

(2)

This regulation overrides anything to the contrary in any other regulation.

Exempt agricultural compounds

5 Agricultural compounds exempt from registration if conditions complied with

(1)

An agricultural compound described in column 1 of Schedule 2 may be imported, manufactured, sold, or used as an agricultural compound without registration under section 21 or 27 of the Act if the conditions described in subclause (2) are complied with.

(2)

The conditions are—

(a)

any conditions set out in relation to that agricultural compound in column 2 of Schedule 2; and

(b)

the applicable conditions in regulations 7 to 13, subject to any express provision in column 2 of Schedule 2 in relation to the particular agricultural compound that has the effect of excluding, modifying, or adding to the requirements in regulations 7 to 13.

(3)

Nothing in these regulations applies to any—

(a)

registered trade name product; or

(b)

substance generally recognised as safe under section 8B of the Act; or

(c)

agricultural compound exempt from registration under section 8C of the Act.

6 Combined agricultural compounds exempt from registration

An agricultural compound is exempt from registration under section 21 or 27 of the Act if the agricultural compound is a combination of 2 or more agricultural compounds that are exempt from registration under these regulations, provided that—

(a)

the conditions applicable to each compound are complied with as described in regulation 5(2); and

(b)

the combined agricultural compound complies with the applicable conditions in regulations 7 to 15, subject to any express provision in column 2 of Schedule 2 in relation to a particular exempt compound in the combination that has the effect of excluding, modifying, or adding to the requirements in regulations 7 to 15.

Conditions of general application to exempt agricultural compounds

An exempt agricultural compound that is imported, manufactured, or sold must be such that, when used as recommended, it will not—

(a)

spread organisms to a level or in a manner that could be harmful to humans; or

(b)

reduce the efficacy of medicines used on humans; or

(c)

result in residues in primary produce that exceed the limits prescribed in applicable food residue standards set in or under any enactment; or

(d)

be toxic to animals treated with or exposed to the compound to an extent that causes unnecessary or unreasonable pain or distress; or

(e)

fail to reduce or eliminate pain or distress to animals treated with the compound where the elimination of pain or distress is a stated purpose of the product; or

(f)

transmit disease, result in physical harm, or cause unnecessary pain and distress, to animals treated with or exposed to the compound; or

(g)

transmit pests or unwanted organisms as defined in the Biosecurity Act 1993 or specified in any national or regional pest management plan made under that Act; or

(h)

otherwise create or be likely to create any of the risks specified in section 4(a) of the Act.

Regulation 7(g): amended, on 18 September 2012, by section 93 of the Biosecurity Law Reform Act 2012 (2012 No 73).

8 Fitness for purpose: use of exempt agricultural compound

A person who uses an exempt agricultural compound must ensure that the use of the compound does not do anything described in regulation 7(a) to (h).

9 Manufacture of exempt compound product to be in accordance with documented system

(1)

An exempt compound product manufactured in New Zealand must be manufactured in accordance with a documented system for the manufacture of that product that contains the following:

(a)

the specifications for the product and specific processes to be followed, and requirements to be met, that are sufficient to ensure that the product, when used as recommended, complies with the conditions of exemption applicable to the product under these regulations; and

(b)

the formulation or recipe of the product; and

(c)

a description of the manufacturing process; and

(d)

the name or description under which the product will be sold in New Zealand; and

(e)

a description or illustration of any packaging and labelling requirements for the product; and

(f)

a nominated person or persons to monitor compliance with the requirements of the documented system; and

(g)

any other matter relevant to the manufacture of the product that is specified by the Director-General.

(2)

If a product is imported into New Zealand that, when ready for sale, will be an exempt compound product and any process of manufacture of the product occurs in New Zealand, that manufacturing must be in accordance with a documented system that contains the matters described in subclause (1)﻿(c) to (g).

10 Compounded veterinary preparation to be prepared in accordance with documented system

A compounded veterinary preparation must be prepared in accordance with a documented system for that preparation that contains the following:

(a)

the description of the preparation that is supplied to users; and

(b)

the formulation or recipe of the preparation; and

(c)

a description of the compounding process that is sufficient to ensure that the preparation, when used as recommended, complies with the conditions of exemption applicable to the preparation under these regulations; and

(d)

a description or illustration of packaging and labelling requirements (if any) for the preparation; and

(e)

a nominated person or persons to monitor compliance with the requirements of the documented system (which must be, or include, the compounding veterinarian); and

(f)

any other matter relevant to the preparation that is specified by the Director-General.

11 Regulations 9 and 10 not to apply if operating plan required

Nothing in regulation 9 or 10 applies in respect of an agricultural compound that is exempt from registration under section 21 or 27 of the Act on the condition (specified in these regulations) that an applicable operating plan is approved and complied with.

12 Information requirements

(1)

This regulation applies to—

(a)

an exempt compound product, when supplied to a user; and

(b)

a compounded veterinary preparation, when supplied with a label to a user.

(2)

The product or preparation must be supplied with the following information:

(a)

the name (if any) under which it is sold or supplied; and

(b)

a description of the product or preparation sufficient to enable the user to determine the nature and purpose of it; and

(c)

the name and contact details of the manufacturer or importer or, in the case of a compounded veterinary preparation, the compounding veterinarian; and

(d)

the active ingredients; and

(e)

directions for use; and

(f)

use-by date or expiry date, if applicable; and

(g)

details of precautions (if any) to be taken to prevent or manage the risks described in section 19 of the Act when using the product or preparation; and

(h)

in the case of an exempt compound product only, the batch number or other information sufficient to allow the date and place of manufacture or preparation to be ascertained; and

(i)

any other information specified in Schedule 2 in relation to the exempt compound, or exempt compounds, concerned.

This regulation applies to any advertisement or label in relation to an exempt compound product or compounded veterinary preparation.

(2)

No advertisement or label referred to in subclause (1) may include any comment, reference, or explanation in relation to the nature, suitability, quantity, quality, strength, purity, composition, weight, origin, age, effects, proportion, ingredients, or components of the product or preparation, or its effectiveness for any particular purpose, that is inconsistent with the conditions to which that product or preparation is subject under these regulations.

14 Recording of documented system and of actions taken in accordance with documented system

(1)

A documented system must be recorded or otherwise maintained in a manner that enables evidence of the content of it at any given time to be readily accessible and retrievable.

(2)

A person who manufactures an exempt compound product must, in relation to that product, keep records of the application of the specific processes, and taking of required steps, identified in the documented system in accordance with regulation 9(1)﻿(a).

(3)

Where a compounded veterinary preparation is prepared, the compounding veterinarian must, in relation to that preparation, keep records of—

Part A. Exemptions relating to agricultural compounds that could be used in relation to either animals or plants

1

In vitro diagnostics used to confirm the presence or absence of disease or as an aid in the diagnosis of disease or abnormal conditions

2

Substance or compound (not being an agricultural compound described elsewhere in this schedule)—

(a)

prepared by a person (person A) for use on animals or plants owned by person A, or in any land, place, or water owned or occupied by person A (and not for sale); or

(b)

used by person A, or a person employed or engaged by person A, or another person expressly authorised by person A, as described in paragraph (a)

If the substance or compound is used by a person employed or engaged by person A or another person expressly authorised by person A, the use must be in accordance with written instructions from person A about—

(a)

how the substance or compound is to be stored, prepared for use, administered, applied, and (if applicable) disposed of; and

(b)

how the safety and welfare of any person or animal who may come into contact with the substance or compound is to be protected and how any pain or distress of an animal is to be mitigated; and

(c)

how third parties are to be contacted or advised of the use of the substance or compound and warned of any hazards relating to the use of the compound

The following substances or compounds may be prepared or used as described in column 1 only in compliance with an approved operating plan:

(a)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(b)

antibiotic active ingredients:

(c)

hormones:

(d)

substances that are prohibited by countries importing New Zealand primary produce:

(e)

vertebrate toxic agents

3

Agricultural compounds used for—

(a)

any investigative, analytical, experimental, or diagnostic work or toxicity or potency testing work that involves any agricultural compounds; or

(b)

any work that is carried out for the purpose of testing the safety or efficacy of any agricultural compound; or

(c)

any training or teaching of persons, of a kind specified in the approved operating plan, involving agricultural compounds, within the scope of the substances or compounds specified in the plan

An operating plan covering the type or class of agricultural compounds the person or organisation wishes to use for research, testing, or training, and the nature of the activities contemplated must have been approved and must be complied with

The person or organisation subject to the operating plan must, on an ongoing basis, notify the Director-General if a substance or compound is to be used that was not notified to the Director-General as being used or contemplated for use at the time the operating plan was approved, even where the substance or compound to be used is within the scope of agricultural compounds approved for use under that operating plan

4

Vertebrate and invertebrate attractants and repellants that are not applied directly to animals or plants

5

Invertebrate mating disrupters that are not applied directly to animals or plants

6

Agricultural compounds used to control the characteristics of water where—

(a)

the water is used on or in relation to animals or plants; and

(b)

the characteristic must be controlled to maintain the animals or plants in a healthy state or to facilitate the management of the animals or plants

7

Sterilisers, sanitisers, and disinfectants (excluding fumigants) used to maintain hygienic conditions for the purposes of hygiene and pest management in places where animals and plants are housed or cultivated

Animals and plants must not be exposed to the substance or compound

Part B. Exemptions relating to agricultural compounds that could be used in relation to animals

8

Preparations scheduled as medicines under the Medicines Act 1981, and used as veterinary medicines

Must not be used on animals except under the direct care, or with the authorisation, of a veterinarian

12

13

14

Markers, paints, and dyes used as pigments or colourants for topical application to identify animals temporarily

15

Over-the-counter first aid preparations, including general disinfectants, antiseptics, and sanitisers

Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption

16

Topical preparations for animals—

(a)

containing ingredients not able to be absorbed through the skin; and

(b)

used solely to treat minor injuries or to prevent minor dermatological abnormalities; and

(c)

that do not include any of the following ingredients:

(i)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(ii)

antibiotic active ingredients:

(iii)

hormones:

(iv)

substances that are prohibited by countries importing New Zealand primary produce

Must not be used on the teats of lactating animals if the milk of the animals is intended for human consumption

17

Topical hoof preparations—

(a)

containing ingredients that act only on the surface to which they are applied; and

(b)

used solely to treat or prevent minor injuries or abnormalities of the surface of the hoof; and

(c)

that do not include any of the following ingredients:

(i)

active ingredients that are prescription medicines or restricted medicines (as those terms are defined in the Medicines Act 1981):

(ii)

antibiotic active ingredients:

(iii)

substances that are prohibited by countries importing New Zealand primary produce

18

Non-medicated antidiarrhoeal preparations that—

(a)

are used solely as gastrointestinal adsorbent or protectant agents; and

(b)

do not make claims in relation to binding any specific micro-organism or toxin

The label information must include statements that—

(a)

the preparation is suitable for use without veterinary advice only in the treatment of minor cases of diarrhoea; and

(b)

the preparation will not treat dehydration; and

(c)

if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

19

Non-medicated orally and rectally administered laxatives and lubricants used on animals

The label information must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

20

Non-medicated moist or dry poultice preparations used on animals that—

(a)

are used to treat or prevent inflammation, swelling, or pain solely by heating or cooling, or drawing fluid from, the affected area; and

(b)

are intended for use on intact skin or minor wounds

The label must include a statement that, if the preparation fails to alleviate the condition being treated, the user should seek veterinary advice

21

Cauterising preparations used or applied superficially

The label must include a statement that, if the preparation fails to stop bleeding, the user should seek veterinary advice

22

Oral urinary tract modifiers (acidifiers and alkalisers) that are used solely for modification of urinary pH

Must be packaged for sale in dosage-size packages (not in bulk or concentrated form) appropriate for the animals for which the agricultural compound is recommended

23

Respiratory tract modifiers (expectorants and cough suppressants) for use on animals that—

(a)

have only a locally acting, superficial effect on the respiratory tract; and

(b)

are given orally, applied topically to the nose, or inhaled; and

(c)

are used solely in animals to promote mucolysis, for cough suppression (by alleviating only irritation), and to relieve compromised airways and upper respiratory tract congestion

Must be packaged for sale in dosage-size packages (not in bulk or concentrated form) appropriate for the animals for which the agricultural compound is recommended

24

Agricultural compounds used to extend animal semen or to be used as media for animal sperm, cells, ova, and embryos

25

Any agricultural compound (not being an intra-ruminal device) ingested by an animal as feed, or a nutritional preparation intended for oral administration to an animal to achieve a nutritional benefit (oral nutritional compound)

The directions for use on the label must specify the species, type, and class of animal for which use is intended

An agricultural compound that is a therapeutic or pharmacological substance or preparation may be incorporated into oral nutritional compounds only if—

Reprints notes

1 General

This is a reprint of the Agricultural Compounds and Veterinary Medicines (Exemptions and Prohibited Substances) Regulations 2011 that incorporates all the amendments to those regulations as at the date of the last amendment to them.

2 Legal status

Reprints are presumed to correctly state, as at the date of the reprint, the law enacted by the principal enactment and by any amendments to that enactment. Section 18 of the Legislation Act 2012 provides that this reprint, published in electronic form, has the status of an official version under section 17 of that Act. A printed version of the reprint produced directly from this official electronic version also has official status.